This page explains the basics of medical device quality system auditing, and we provide a form for you to request an audit quote.
Who creates the audit quote?
The form below provides us with the basic information we need to prepare an audit quote for your company. There are instructions below the form that explain exactly what information we are looking for in each section of the form. The quotation process is not automated. A real person (i.e. Lindsey Walker) will get back to you with a quotation. She is our audit program manager. She creates the audit quote and assigns the auditors based upon availability and your auditing needs. Her email is email@example.com. The quotation will be automatically emailed from Freshbooks once she is finished, and then she will follow up with a manual email–just-in-case your spam filters prevent delivery of the automated email generated by FreshBooks. If Lindsey is on vacation, or out sick, the proposal will be prepared by Rob Packard. His email is firstname.lastname@example.org.
General Pricing of an Audit Quote
If you are looking for the cheapest audit you can find, don’t even bother filling in the form. Our goal is to help you improve your quality system and provide valuable consulting advice to achieve improvements. We specialize in helping start-up companies achieve initial ISO 13485 certification, MDSAP certification, and CE Certification. We will assign an experienced lead auditor with an hourly consulting rate of $275/hour. Typically, we will charge $2,750 plus travel expenses for a one-day supplier audit because we expect to spend 30 minutes on audit preparation, eight hours on-site actively auditing, and 2+ hours generating an audit report. Most quotations are flat-fee quotations so you know exactly how much you will be charged. We also request a 50% deposit for audits.
Name, Company, Email & Phone
- Internal Audit – This is also called a “1st party audit,” and these are conducted to evaluate the effectiveness of your quality system. You are required to conduct an audit of the full quality system each year. If you select “Internal Audit,” we will assume that you want us to provide an audit quote for your complete quality system. If you only want a partial quality system audit of one or more process areas, then please select “Individual Process” and specify which process or processes in the text box labeled “Process Areas to Audit.”
- Supplier Audit – This is also called a “2nd party audit,” and these are conducted to evaluate the effectiveness of your supplier’s quality system. Other reasons for a supplier audit include verifying compliance with contractual requirements or identifying the root cause of a quality problem (i.e. nonconforming product). Please provide the details of what processes to audit in the text box labeled “Process Areas to Audit.” We generally recommend focusing supplier audits on the activities you are outsourcing (e.g. manufacturing) rather than general quality system requirements (e.g. management review).
- Individual Process Audit – This is also a “1st party audit,” however, we will focus on one or more processes that you identify in the text box labeled “Process Areas to Audit.” This type of audit is ideal when you do not have a qualified auditor that is independent to audit a process. Another scenario where this type of audit is valuable is when you recently made a significant change to a process and you want to verify that the employees are following the new process, or if you want to verify the effectiveness of corrective actions implemented for a specific process. For example, you want to verify the effectiveness of a CAPA related to an FDA 483 or Notified Body nonconformity.
Process Areas to Audit
Location (Remote or On-Site) for Audit Quote
Desired Date or Dates
Duration of Audit in Hours
Auditing Criteria for Audit Quote
- 21 CFR 820, 803, 806, and 830 – the US FDA regulations including medical device reporting, corrections and removals, and unique device identifier regulations
- ISO 13485:2016/Amd 2021 – the international quality system standard for medical device manufacturers
- Regulation (EU) 2017/745 – the European Medical Device Regulations
- SOR 98/282 – the Canadian Medical Devices Regulation
- MDSAP AU P0002.006 – the Medical Device Single Audit Program audit approach guidance document